Ultrasound probe with an integrated needle assembly and a computer program product, a method and a system for providing a path for inserting a needle of the ultrasound probe

ABSTRACT

A device and system for and methods of using an ultrasound probe housing containing ultrasound probes configured to produce images inside the body of a patient for procedures requiring needle or probe insertion. The ultrasound probe housing can be configured with a guide channel cut-out or aperture between the ambient side and body side of a patient. A needle guide assembly may be pivotally connect internal to the guide channel cut-out or aperture of the ultrasound probe housing at a pivot point such that during use the needle enters the patient through the needle guide assembly within the ultrasonic probe housing so that the needle can be visualized by the ultrasonic probes in real time. The ultrasound probe housing may also provide an adhesion or suction quality to the body side of the device to facilitate aspects of the invention.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/445,355, filed Jun. 19, 2019, the entirety of which is incorporatedby reference herein.

FIELD OF THE INVENTION

Embodiments of the present invention generally relate to application ofultrasonic waves in medical procedures and more particularly to anultrasound probe with an integrated needle assembly and a computerprogram product, a method and a system for providing a path forinserting a needle of the ultrasound probe.

BACKGROUND ART

Procedures that require needle penetration are some of the most commonmedical procedures, yet remain relatively unchanged since theirinception in 1891. In a typical scenario, a practitioner uses palpationof landmarks, such as the iliac crests and the spinous processes, toguide location of a needle during a blind procedure. Examples of suchprocedures include lumbar puncture (LP), epidural and spinal injections,and spinal nerve blocks. Failure rate of one of the most common medicalprocedures, lumbar puncture, however, is about 20% owing to thedifficulty of identifying landmarks and the inability to visualize thelocation and trajectory of the needle. This rate is expected to increaseas obesity increases in the global population. While ultrasound has beenused to aid in the identification of structural landmarks, needleinsertion continues to be an obstructed or blind procedure withoutsignificant improvement in success rates with using static ultrasound.Failure of a bedside lumbar puncture consequently leads to afluoroscopic lumbar puncture which results in increased cost,unnecessary inpatient admissions and delay in patient care.Additionally, pain control and anesthesia has increasingly includedlocal and regional nerve blocks. These procedures can use eitherlandmarks or are limited to two-dimensional (2D) ultrasound, whichlimits the number of providers choosing this method due to the highinitial skill required for a successful procedure. For example, femoralnerve blocks are increasingly being utilized to decrease the need foropiate pain control after hip fractures, which are proven to haveimproved pain control and decrease adverse events.

Several recent approaches are meant to address the above mentionedproblems. But each approach continues to have multiple system or uselimitations. For example, certain systems include ultrasound deviceswith an attached needle. These devices, however, are limited in functionat least by the location or attachment of the needle away from theultrasound transducer itself such that the needle is outside of thefield of view provided by the ultrasound transducers. Other devicesprovide a needle that has restricted movement yielding inadequateprocedural flexibility. Additionally, other certain available devicesprovide inadequate image viewing, such as with 2D imaging, that makeneedle tracking or visualization more difficult for the medicalpractitioner. These systems also suffer from the inability to provide apredicted optimum path within the patient for needle travel. Obstructedimage viewing of the needle path and inability to predict the path ofthe needle leads to procedure failure. Overall, there remains anenhanced risk of injuring the anatomical parts of the body such as thetissues, nerves etc. that are located near the target internal bodypart.

Therefore, a need exists in the art for an ultrasound probe with anintegrated needle assembly and a computer program product, a method anda system for providing a path for inserting a needle of the ultrasoundprobe which does not suffer from above mentioned deficiencies.

SUMMARY OF THE INVENTION

In accordance with teachings of the present invention a device forproviding a path for inserting a needle inside a body of a patient forperforming medical procedures is provided.

An object of the present invention is to provide a device having anultrasound probe housing, a guide channel cut-out or aperture, and aneedle guide assembly. The ultrasound probe housing generates ultrasoundwaves to produce images inside of the body of a patient. The ultrasoundprobe housing has an ambient side and a body side and can be of anyshape meeting the requirements of the invention. The ultrasound probehousing may also provide an adhesion or suction quality to the body sideof the device to facilitate aspects of the invention.

The guide channel cut-out or aperture is configured between the ambientside and the body side through the ultrasound probe housing. The needleguide assembly may pivotally connect internal to the guide channelcut-out or aperture on the body side of the ultrasound probe housing ata pivot point. The needle guide assembly receives a needle. A needle isadapted to slide within the needle guide assembly such that during usethe needle enters the patient through the needle guide assembly withinthe ultrasonic probe housing so that the needle can be visualized by theultrasonic probes in real time.

Another object of the invention is to provide a device with a rotationangle sensor. The rotation angle sensor is configured at or near thepivot point and connected with the needle guide assembly or sufficientlyclose to the needle guide assembly to approximate the needle anglewithin the assembly. Further, the rotation angle sensor can be apotentiometer.

Another object of the invention is to provide a device with a rotationangle sensor. The rotation angle sensor is configured at or near thepivot point and connected with the needle guide assembly or sufficientlyclose to the needle guide assembly to approximate the needle anglewithin the assembly. Further, the rotation angle sensor can be apotentiometer.

Another object of the invention is to provide a device with a lockingmechanism that will hold the angular position of the needle to a fixedposition as selected by the operator as to hold the needle in a fixedangular position while the procedure is being conducted.

Another object of the invention is to provide a device with an angle ofrotation of the needle guide assembly inside the guide channel cut-outor aperture of the ultrasound probe housing. The guide channel cut-outor aperture may be a slot within the ultrasound probe housing giving anangle of rotation within a range of 0 degrees to roughly 180 degrees, ormay be a more complex shape, such as conical shape, to further increasethe degree of rotation of the needle guide assembly beyond that of aslotted shape. Further, the needle guide assembly is configured to beactuated by either mechanical unit or electrical unit. A person skilledin the art may appreciate that range of motion of the needle guideassembly may be assisted by the use of movement aids such as a bearingcollar.

Another object of the invention is to provide the device with a pressuretransducer is configured to be disposed in the needle.

Another object of the invention is to provide a path for inserting aneedle into a body of a patient for performing medical proceduresinvolving an ultrasound probe. The method includes steps of receivingimages of inside of body of a patient generated corresponding toreflected ultrasonic waves, from an ultrasonic probe housing, generatingreal-time 3-Dimensional (3D) images of anatomical parts of the bodybetween the ultrasound probe and a target internal body part, displayingthe real-time 3D images on a display device connected with theultrasound probe, optionally comparing the real-time 3D images withpre-stored reference data stored in a data repository, and providing apath for inserting the needle through the ultrasound probe towards thetarget internal body part. A path or paths may be displayed as a visualoverlay on the display device displaying the underlying anatomy, and maybe generated with the assistance of computer software, for example withthe use of artificial intelligence. The path or paths may be based onthe available information that is both general (non-patient specific)and/or patient specific. The operator may then accept a path in spacewithin the patient or choose a different path. The system receiving,processing, and providing an output may be a desktop PC, notebook,handheld, or mobile device, such as a smartphone, being linked in awired or wireless form to the ultrasound probe.

Another object of the invention is to provide the step of guiding theneedle on the provided path to the target internal body part through anautomated and rotatable needle guide assembly, wherein the needle beingcovered in the field of view of the ultrasound probe is displayed on thedisplay device during insertion.

Another object of the invention is to provide the step of guiding theneedle on the provided path to the target internal body part using aneedle insertion handle provided on the needle through the rotatableneedle guide assembly, wherein the needle being covered in the field ofview of the ultrasound probe is displayed on a display device duringinsertion, and wherein the needle insertion handle provides enhancedmaneuverability for the practitioner/user.

Another object of the present invention is to provide the step ofproviding one or more of 3D images of the previously performed medicalprocedures, previously provided paths for similar procedures and imagesand details of anatomical parts of the body. Such images may be specificto the patient having the procedure performed with the device or methodof the invention, and may be general in nature.

An object of the present invention is to provide a device having anultrasound probe housing. The ultrasound probe housing generatesultrasound waves to produce images inside of the body of a patient. Theultrasound probe housing has an ambient side and a body side. Theultrasound probe housing provides an adhesion or suction quality to thebody side of the device.

Another object of the device is to allow the ultrasound array and othervarious device components to be removed, maintained, or replaced forsterility, cleaning and other maintenance functions.

BRIEF DESCRIPTION OF THE DRAWINGS

So that the manner in which the above recited features of the presentinvention can be understood in detail, a more particular description ofthe invention, briefly summarized above, may have been referred byexamples, some of which are illustrated in the appended drawings. It isto be noted, however, that the appended drawings illustrate only typicalexamples of this invention and are therefore not to be consideredlimiting of its scope, for the invention may admit to other equallyeffective examples.

These and other features, benefits, and advantages of the presentinvention will become apparent by reference to the following textfigure, with like reference numbers referring to like structures acrossthe views, wherein:

FIG. 1 illustrates a perspective view of a device providing a path forinserting a needle for performing medical procedures, in accordance withan embodiment of the present invention;

FIG. 2 illustrates another perspective view of a device providing a pathfor inserting a needle for performing a medical procedure, in accordancewith another embodiment of the present invention;

FIG. 3A illustrates a front view of a device in accordance with anembodiment of the present invention;

FIG. 3B illustrates a front view of a device in accordance with anotherembodiment of the present invention;

FIG. 4A illustrates a perspective view of a needle guide assembly inaccordance with an embodiment of the present invention;

FIG. 4B provides another perspective view of needle in accordance withan embodiment of the invention;

FIG. 5 illustrates a method for providing a path for inserting a needleof the ultrasound probe inside a body of a patient, in accordance withan embodiment of the present invention;

FIG. 6 illustrates a system for providing a path for inserting a needlefor medical procedures, in accordance with an embodiment of the presentinvention;

FIG. 7 illustrates a schematic diagram of performing medical procedureson the patient using a device in which a pathway for needle insertioninto the patient is provided, in accordance with an embodiment of thepresent invention;

FIG. 8A illustrates a perspective view of the device providing a pathfor inserting a needle for performing a medical procedure, in accordancewith an embodiment of the present invention;

FIG. 8B illustrates a perspective view of the device providing a pathfor inserting a needle for performing a medical procedure, in accordancewith another embodiment of the present invention;

FIG. 9A illustrates a perspective view of the device providing a pathfor inserting a needle for performing medical procedure, in accordancewith another embodiment of the present invention;

FIG. 9B illustrates a perspective view of the device providing a pathfor inserting a needle for performing medical procedure, in accordancewith another embodiment of the present invention

FIG. 9C illustrates a top view of the device providing a path forinserting a needle for performing medical procedure, in accordance withanother embodiment of the present invention;

FIG. 9D illustrates a side view cutaway of the device providing a pathfor inserting a needle for performing medical procedure, in accordancewith another embodiment of the present invention;

FIG. 10A illustrates a bottom view of the ultrasound probe housinghaving adhesion points located at the perimeter of the body side of thedevice in accordance with another embodiment of the present invention.

FIG. 10B illustrates a bottom view of the ultrasound probe housinghaving adhesion points located at the perimeter of the body side of thedevice in accordance with another embodiment of the present invention.

FIG. 11A illustrates a bottom view of the ultrasound probe housinghaving adhesion points located at the perimeter of the body side of thedevice in accordance with another embodiment of the present invention.

FIG. 11B provides a side cutaway view of the ultrasound probe housinghaving adhesion points located at the perimeter of the body side of thedevice in accordance with another embodiment of the present invention.

FIG. 12A illustrates a bottom view of the ultrasound probe housinghaving adhesion points located across the body side of the device inaccordance with another embodiment of the present invention.

FIG. 12B illustrates a side cutaway view of ultrasound probe housing inwhich adhesion points and holes are apparent and opened to body side ofthe device in accordance with another embodiment of the presentinvention.

FIG. 13A illustrates a perspective view of the ultrasound probe housinghaving adhesion points located across the body side of the device inaccordance with another embodiment of the present invention.

FIG. 13B illustrates a side view of ultrasound probe housing in whichadhesion points and adhesive pads are apparent on body side of thedevice in accordance with another embodiment of the present invention.

DETAILED DESCRIPTION OF THE EMBODIMENTS

While various embodiments of the present disclosure are provided herein,it should be understood that they are presented as examples only, andare not intended to be limiting. Similarly, the drawings and diagramsdepict structural or architectural examples or alternate configurationsof the invention, which are provided to aid in understanding thefeatures and functionality of the various embodiments of the inventionbut are not intended to be limiting. The embodiments and features may beimplemented and/or altered in a variety of ways known to those ofordinary skill the art.

FIG. 1 illustrates a perspective view of a device 100 providing a pathfor inserting a needle 102 for performing medical procedures, inaccordance with an embodiment of the present invention. The device 100includes an ultrasound probe housing 104, a guide channel cut-out oraperture 106, and a needle guide assembly 108. In another embodiment ofthe present invention, the device 100 further includes a pivot point 110and rotation angle sensor 111.

The ultrasound probe housing 104 contains a series of probes 105 (notshown) that generate ultrasound waves to produce images of inside ofbody of a patient. Ultrasound probe housing 104 having an ambient side112 and a body side 114. Ultrasound probe housing 104 is explained indetail throughout and, for example, in conjunction with FIG. 3 of thepresent invention.

Guide channel cut-out or aperture 106 is configured between the ambientside 112 and the body side 114 through ultrasound probe housing 104. Aneedle guide assembly 108 pivotally connects to the guide channelcut-out or aperture 106 on the body side 114 of the ultrasound probehousing 104 at pivot point 110. The needle guide assembly 108 receives aneedle 102. Needle 102 is adapted to slide in needle guide assembly 108such that needle 102 enters the field of view of the ultrasonic probehousing 104 upon insertion into the tissue of the patient receiving theprocedure.

In an embodiment of the present invention, pivot point 110 is locatednear to left side 107 of the guide channel cut-out or aperture 106.However, it would be readily apparent to those skilled in the art tomove pivot point 110 in the guide channel cut-out or aperture 106 toincrease angle of rotation of needle 102 without deviating from thescope of the present invention.

Needle guide assembly 108 pivotally moves inside the guide channelcut-out or aperture 106 between a vertical setting and a shallowsetting. As shown in FIG. 1 , needle guide assembly 108 is at verticalsetting. However, it would be readily apparent to those skilled in theart that the guide channel cut-out 106 may be created in multiple shapessuch as circular, conical, hyperboloid, etc. to increase the angle ofrotation to a desired angle without deviating from the scope of thepresent invention. The angle of rotation of the needle guide assembly108 is explained by way of example in detail in conjunction with FIGS. 8and 9 of the present invention.

Further in another embodiment of the present invention, the rotationalangle sensor 111 is configured at pivot point 110 and connected withneedle guide assembly 108 to measure needle location. The rotationalangle sensor 111 is a potentiometer. In another embodiment of thepresent invention, the angle of rotation of the needle guide assembly108 inside the guide channel cut-out or aperture 106 is in the range of0 to 180 degrees.

In another embodiment of the present invention, device 100 furtherincludes a needle insertion handle 116 for allowing practitioner/user706 to hold and move needle 102 inside needle guide assembly 108. Needleguide assembly 108 is a rigid housing that is manually or automaticallyadjusted and provides a predetermined and rigid path to allow forprecise needle insertion to the target. Needle insertion handle 116 maybe a conventional cuboid plastic grip but can be modified for improvedcontrol and tactile response required in a procedure. Needle insertionhandle 116 may include a plastic (or suitable material) shape such as awing tip, protrusion, or fingerhold that resides at a distance away fromthe end of the needle to allow for more control with needle insertion,as shown in FIG. 1 . Modifying needle insertion handle 116 may obviatepractitioner/user 706 need or desire to handle needle 102 directlyduring the procedure. Further, needle guide assembly 108 will stabilizeneedle 102 in the x axis to improve practitioner/user 706 needle usage.

FIG. 2 illustrates another perspective view of the device 100 providinga path for inserting needle 102 for performing medical procedure, inaccordance with another embodiment of the present invention. Needleguide assembly 108 is at the shallow setting.

Needle guide assembly 108 is movable by practitioner/user 706 withinguide channel cut-out or aperture 106 at any desired angle.Alternatively, needle guide assembly 108 is actuated either by amechanical unit (such as levers) or an electrical unit (such as roboticarm). In another embodiment of the present invention, device 100 mayfurther include a cord 202 to supply power and transmit data toultrasound probe housing 104.

In another embodiment of the present invention, guide channel cut-out oraperture 106 is a U shape cut at the edge of the ultrasound probehousing 104. However, it would be readily apparent to those skilled inthe art that various shapes (such as V-shaped) and place (such ascenter) to create the guide channel cut-out or aperture 106 on theultrasound probe housing 104 may be envisioned without deviating fromthe scope of the present invention.

FIG. 3A illustrates a partial front view of device 100 in accordancewith an embodiment of the present invention. Ultrasound probe housing104 contains probes 105 that generate ultrasonic waves, receive thereflected ultrasonic waves and generate data in the form of electricalsignals corresponding to the received ultrasonic waves.

Ultrasound probe housing 104 generates real-time 3-Dimensional (3D)images of anatomical parts of the body of the patient. A field 302 showsthe viewable image area beneath and near the ultrasound probe housing104. As shown by example in FIG. 3B, the array of probes 105 may bepositioned within ultrasound probe housing 104 to alter the viewableimage of field 302. In certain formats, probes 105 may be angled withinultrasound probe housing 104 to optimize the viewable image at the siteof needle penetration beneath ultrasound probe housing 104. This may behelpful to accommodate changes to the structure of guide channel cut-outor aperture 106. Likewise, probes 105 may be positioned perpendicular tobody side 114 of ultrasound probe housing 104 to give a wider viewableimage area. Ultrasound probe housing 104 may also contain a mixed arrayof angled and perpendicular probes 105 to alter viewable imagegeometries. It would be readily apparent to those skilled in the artthat various types and shapes of ultrasound probe housing 104 containingprobes 105 may be envisioned without deviating from the scope of thepresent invention.

FIG. 4A illustrates a perspective view of needle 102 in accordance withan embodiment of the present invention. In another embodiment of thepresent invention, device 100 further includes plurality of guidebearings 402 to facilitate sliding motion of needle 102 in needle guideassembly 108 (as shown by example in FIG. 1 to FIG. 3 ). Needle guideassembly 108 stabilizes needle 102 during insertion into the patientbody and attaches needle 102 to ultrasound probe housing 104.

FIG. 4B provides another perspective view of needle 102 in accordancewith an embodiment of the invention. FIG. 4A further includes exemplaryneedle insertion handle 116. It will be appreciated that examples ofguide bearings 402 include but are not limited to 1 or more slidingbearings designed to allow needle 102 to move in the radial direction,restricts the needle from bending on insertion, and maintains the needleposition in space.

FIG. 5 illustrates a method 500 for providing a path for insertinginside a body of a patient during medical procedures involving anultrasound probe housing in accordance with an embodiment of the presentinvention. The method 500 initiates with a step 502 of receiving imagesof inside of body of a patient, generated corresponding to reflectedultrasonic waves from probes 105 of ultrasonic probe housing 104.Ultrasonic probe housing 104 of step 502 is explained in detail inconjunction with FIG. 1 and FIG. 3 of the present invention.

Step 502 is followed by a step 504 of generating real-time 3-Dimensional(3D) images of anatomical parts of the body between the ultrasound probeand an internal target body location. Data from ultrasound probe housing104 is transmitted to a processor. The processor processes received dataand generates 3D images of anatomical parts in real-time.

Step 504 is followed by a step 506 of displaying the real-time 3D imageson a display device receiving information from device 100. The processorprocesses the data received from the ultrasound probes and the displaydevice displays the processed data. The display device may also displaya predicted path 705 of needle 102 based on the current body location ofdevice 100 and current needle angular position. Predicted path 705represents the path that needle 102 would take through the patientanatomy if needle were extended in space from and based on its currentcoordinates. The display device and the processor is explained hereinand also in further conjunction with FIG. 6 of the present invention.

Step 506 may optionally be followed by a step 508 of comparing the realtime 3D images and data with reference data stored in a data repository608 (as shown by example in FIG. 6 ). Data repository 608 may also be ata remote location but accessible in real time, such as with cloudstorage. Further, step 506 or 508 may then be followed by step 510 ofproviding a recommended path 707 for inserting needle 102 through theultrasound probe housing towards the internal target body location.Recommended path 707 is a path through the anatomy of the patient basedon available data that may include current real time data from device100, stored data, and the type of procedure to be performed. Therecommended path 707 for inserting needle 102 through the ultrasoundprobe is displayed on the display device. Both the distance and angle ofthe device from its current position to the position matching that ofthe recommended path can be displayed to enable practitioner/user 706 torelocate the device on the patient body to be able to match therecommended path. Predicted path 705 and recommended path 707 may differfrom each other. Practitioner/user 706 has the option to use therecommended path 707 or to select an alternate path based on the realtime 3D image display and predicted path 705.

Examples of the pre-stored data include but not limited to one or more2D and 3D images of the previously performed medical procedures that canbe patient-specific, previously provided paths for similar procedures,and images and details of anatomical parts of the body, etc.

In an exemplary embodiment of the present invention, the 3D image showsa kidney of a patient in real time, then the processor compares the realtime 3D image with the pre-stored data. The pre-stored data showcase thepath for inserting needle 102 that corresponds to the image of thekidney. The desired path to perform the medical procedure is displayedon the display device depending upon the real time image.

It would be readily apparent to those skilled in the art that artificialintelligence may be involved at various stages of information usage forthe device. For example, AI may assess the path of treating the internaltarget body location from the data repository 608 (shown in FIG. 6 ) andmay identify a recommended path 707 (shown in FIG. 7 ) on receiving thesimilar situation without deviating from the scope of the presentinvention.

FIG. 6 illustrates a system 600 for providing a path or paths forinserting needle 102 for medical procedures, in accordance with anembodiment of the present invention. The system 600 further includes anultrasound probe housing 104, a guide channel cut-out or aperture 106,needle guide assembly 108, a processor 602, a memory unit 604, a datainterface 606, a data repository 608 and a display unit 610.

The ultrasound probe housing 104, the guide channel cut-out or aperture106 and needle guide assembly 108 are explained in detail in conjunctionwith exemplary FIG. 1 to FIG. 3 of the present invention. Processor 602is connected with the ultrasound probe housing 104 through the datainterface 606, which may or may not be a physical, wired connection. Forinstance, data interface 606 may receive data from a wireless, cellular,or bluetooth connection.

The data interface 606 receives data from the ultrasound probe housing104 and transfers the received data to the processor 602 for processing.Examples of the processor 602 can include any system that processesimages to predict and map the real patient's anatomy during the liveprocedure based on changes in echogenecity during the ultrasound. Thiscan include the use of AI or other simulated intelligent programs.

The memory unit 604, the display unit 610 and the data repository 608are connected with the processor 602, and may each be stand-aloneequipment or could be a composite device, such as a desktop PC,notebook, handheld, or mobile device, such as a smartphone. The memoryunit 604 stores the instructions, the processor 602 processes the storedinstructions and the display unit 610 displays the processedinstructions. The instructions are explained in the conjunction withFIG. 5 (method 500) of the present invention.

Examples of the memory unit 604 include but not limited to a fixedmemory unit or a portable memory unit that can be inserted into thedevice. It will be appreciated that memory unit 604 would havesufficient memory to adequately store large volumes of information. Itis expected that each system may offer advantages in certain usesituations. For example, a portable memory unit may also be insertableinto and compatible with an available medical record system forinformation exchange. A fixed memory unit may achieve a similar goal byhaving a port for information exchange. Examples of the display unit 610include but not limited to LCD, LED, OLED, TFT, or any specific displayof any unit device capable of visually providing information such as ona desktop PC, notebook, handheld, or mobile device, such as asmartphone.

FIG. 7 illustrates a schematic diagram of performing medical procedureon the patient 700 using the device 100, in accordance with anembodiment of the present invention. In this example, ultrasound probehousing 104 is placed on the back of the patient 700 to perform amedical procedure on spine 702.

The ultrasound probe housing 104 captures images of spine 702 and otheranatomical body parts 704 of patient 700 and displays the images on thedisplay device 610 in real time. The display of spine 702 and anatomicalbody parts 704 allows a practitioner/user 706 to move needle 102, whichis placed inside needle guide assembly 108, through the guide channelcut-out or aperture 106 to perform the required medical procedure on thedesired location of the body part of the patient 700.

Device 100 allows practitioner/user 706 to perform the medical procedurewith greater ease and on the desired location. Due to its locationwithin and through ultrasound probe housing 104, the visibility ofneedle 102 in 3D allows practitioner/user 706 viewing of the desiredlocation from multiple angles for improved procedural accuracy.

Further, FIG. 7 illustrates use of device 100 where the pathway forinsertion of needle 102 through ultrasound probe housing 104 ispredicted and displayed on display unit 610 based on informationcollected in real time and/or from data repository 608 of system 600.The control unit will take the angular position input from thepotentiometer and automatically adjust the optimum angle of needle 102via a motor to pass between anatomical structures, for example, spinousprocesses, for procedural success. The angle of needle 102 may also bemanually managed by a movement mechanism such as a turning dial to set afinal needle path. Practitioner/user 706 can choose to follow predictedpath 705 for needle 102, recommended path 707 for needle 102, or someother path of the operator's choosing. Once practitioner/user 706selects an insertion pathway, needle guide assembly 108 is locked inposition to allow needle 102 to be inserted along the selected path.Depending on the embodiment of the device, practitioner/user 706 wouldalso be able to stabilize the device location relative to the patientbody by actuating attachment features of device 100 discussed herein.The insertion of needle 102 can be manually or automatically driven byor through device 100. It will be appreciated that system 600 will usecomputer processing in determining and displaying predicted path 705 andrecommended path 707, and such processing may be based on artificialintelligence. In another embodiment of the invention, the display devicemay further display anticipated procedural steps to be performed for thespecific procedure being undertaken by practitioner/user 706. Upcomingprocedure steps may be indicated as textual prompts, bubble callouts,audibles, and may also include voice commands or prompts.

FIG. 8A illustrates another perspective view of the device 100 providinga path for inserting a needle 102 for performing the medical procedure,in accordance with another embodiment of the present invention. Thelength of the guide channel cut-out or aperture 106 is extended to allowneedle guide assembly 108 to rotate in both directions within thechannel-like structure, i.e., up to 180 degrees of total range ofmovement. Pivot point 110 is now away from the left side 107 of theguide channel cut-out or aperture 106. The needle guide assembly 108passes through pivot point 110 and thus the angle of rotation increasesfrom approximately 0 to 90 degrees to a fuller range of 0 to 90 degreesand 0 to minus 90 degrees. FIG. 8B provides another example where guidechannel cut-out or aperture 106 provides a greater range of motion overdevice 100 as depicted in exemplary FIG. 1 . In this embodiment, it willbe appreciated that guide channel cut-out or aperture 106 has rotatedfrom the direction provided in FIG. 8A. It will further be appreciatedthat the location of guide channel cut-out or aperture 106 is not fixedso long as needle 102 exits through body side 114 of ultrasound probehousing 104 of device 100 to achieve the purposes of the invention.

FIG. 9 illustrates various views of device 100 for providing a path forinserting needle 102 for performing a medical procedure with guidechannel cut-out or aperture 106 having cone-like geometries. Needleguide assembly 108 pivotally connects to the guide channel cut-out oraperture 106 on or near the body side 114 of the ultrasound probehousing 104 at pivot point 110. In these configurations, needle guideassembly 108 and guide channel cut-out or aperture 106 may use aspherical bearing or similar device that allows needle 102 to rotateboth radially and circumferentially, as shown in FIGS. 9C and 9D. Needle102 is adapted to slide in needle guide assembly 108 such that theneedle 102 is in a field of view of the ultrasonic probe housing 104upon insertion into the tissue of the patient receiving the procedure.It will be appreciated that guide channel cut-out or aperture 106 may bea cone or hyperboloid shape, for example as shown as in FIGS. 9A and 9B,to potentially provide greater degrees of movement over the guidechannel cut-out or aperture 106 as depicture in FIG. 1 . It would bereadily apparent to those skilled in the art that various shapes andsizes of guide channel cut-out or aperture 106 may be envisioned withoutdeviating from the scope of the present invention.

FIG. 10A illustrates a bottom view of ultrasound probe housing 104 ofdevice 100 having adhesion points 115 located on body side 114 ofultrasound probe housing 104. Adhesion points 115, which may furthercontain holes 117, fix or adhere ultrasound probe housing 104 inlocation on the patient to maintain further control of the device forneedle penetration. FIG. 10A depicts adhesion points 115 along theperimeter of ultrasound probe housing 104, but it will be appreciatedthat adhesion points 115 may be located anywhere across body side 114 ofultrasound probe housing 104 so long as they do not interfere with theability of probes 105 to generate the viewable image field required forthe procedure to be performed. FIG. 10A provides adhesion points 115 inthe shape of elongated depressions, but adhesion points 115 may be anyshape, such as channels, cups, cups with lips or pronounced outer edges,or may have no additional contouring different from body side 114 ofultrasound probe housing 104. It will be appreciated that ultrasoundprobe housing 104 may be held in place during the procedure by applyingsuction or tactile adhesion. Holes 117 may provide suction forces toadhesion points 115 in one format and may be a source of skin adhesiveto adhere ultrasound probe housing 104 in place in another format.

FIG. 10B provides a bottom of ultrasound probe housing 104 with no guidechannel cut-out or aperture 106. This embodiment provides the fixingability of ultrasound probe housing 104 as described herein with theability to have needle 102 attached to the ultrasound probe housing 104in an external manner, or to have needle 102 unattached completely perpractitioner/user 706 preference. It will be appreciated that each ofthe devices disclosed having adhesion points 115 may be without guidechannel cut-out or aperture 106 and still provide the ability to fix thedevice to the patient as desired.

FIG. 11A demonstrates a bottom view of ultrasound probe housing 104having adhesion points 115 located at the perimeter of the body side 114of device 100 (shown in FIG. 1 ) in accordance with an embodiment of thepresent invention. FIG. 11B provides adhesion points 115 shaped asdepressions with structure along the perimeter of said depressions tofacilitate suction contact, e.g. suction cups. Adhesion points 115further contain holes 117 through which suction forces may be applied tothe contact point on the patient body. Ultrasound probe housing 104contains internal structure such as tubing or channels for air exchangeto create suction through holes 117. It will be appreciated that theexact architecture needed to facilitate suction forces can vary so longas it does not interfere with the purposes of this invention.

FIG. 11B provides a side cutaway view of ultrasound probe housing 104 inwhich adhesion points 115 and holes 117 are apparent and opened to bodyside 114. It will be appreciated that holes 117 and the correspondingarchitecture within ultrasound probe housing 104 may provide a source ofadhesive instead of suction forces by which to fix device 100.

FIG. 12A illustrates a bottom view of the ultrasound probe housing 104having adhesion points 115 located across body side 114 of device 100 inaccordance with another embodiment of the present invention. Adhesionpoints 115 are also holes 117 in this configuration and have noadditional contouring on body side 114 of device 100. FIG. 12B providesa side cutaway view of ultrasound probe housing 104 in which adhesionpoints 115 and holes 117 are apparent and opened to body side 114. Itwill be appreciated that holes 117 and the corresponding architecturewithin ultrasound probe housing 104 may provide a source of adhesiveinstead of suction forces by which to fix device 100. FIG. 12B providesa side view cutaway for illustrate the exemplary architecture ofultrasound probe housing 104.

FIG. 13A illustrates a bottom view of ultrasound probe housing 104having adhesion points 115 located on body side 114 of device 100 inaccordance with an embodiment of the present invention, where adhesionpoints 115 are ready for use adhesive pads or films 118. Adhesion points115 may further contain a protective cover over adhesive pads or films118 for storage that can be removed at time of use during the surgicalprocedure. It will be appreciated that body side 114 may be a receptaclefor replaceable adhesive pads or films 118 that may be disposed of aftereach procedure. Such disposable adhesive pads or films 118 may besterile. Ultrasound probe housing 104 may contain a removable cover 120that coupleably joins all or a portion of body side 114. Removable cover120 may itself provide adhesive pads or films 118 or the surface foradhesive pads or films 118 that can be fitted to body side 114 of device100 for ease of use. Each removable cover 120 may be sterile andindividually provided to ultrasound probe housing 104 for the specificprocedure. FIG. 13B provides a side view of ultrasound probe housing 104in which adhesion points 115 and adhesive pads or films 118 are apparenton body side 114.

In the foregoing description, it will be readily appreciated by thoseskilled in the art that modifications may be made to the inventionwithout departing from the concepts disclosed herein. Such modificationsare to be considered as included in the following claims, unless theclaims by their language expressly state otherwise.

Terms and phrases used in this document, and variations thereof, unlessotherwise expressly stated, should be construed as open ended as opposedto limiting. As examples of the foregoing: the term “including” shouldbe read as meaning “including, without limitation” or the like; the term“example” is used to provide exemplary instances of the item indiscussion, not an exhaustive or limiting list thereof; the terms “a” or“an” should be read as meaning “at least one,” “one or more” or thelike; and adjectives such as “conventional,” “traditional,” “normal,”“standard,” “known” and terms of similar meaning should not be construedas limiting the item described to a given time period or to an itemavailable as of a given time, but instead should be read to encompassconventional, traditional, normal, or standard technologies that may beavailable or known now or at any time in the future. The variousembodiments set forth herein are described in terms of exemplary blockdiagrams and other illustrations. As will become apparent to one ofordinary skill in the art after reading this document, the illustratedembodiments and their various alternatives can be implemented withoutconfinement to the illustrated examples. For example, block diagrams andtheir accompanying description should not be construed as mandating aparticular architecture or configuration.

Although the disclosure is described above in terms of various exemplaryembodiments and implementations, it should be understood that thevarious features, aspects and functionality described in one or more ofthe individual embodiments are not limited in their applicability to theparticular embodiment with which they are described, but instead can beapplied, alone or in various combinations, to one or more of the otherembodiments of the disclosure, whether or not such embodiments aredescribed and whether or not such features are presented as being a partof a described embodiment.

What is claimed is:
 1. A device comprising: an ultrasound probe housinghaving an ambient side and a body side, the ultrasound probe housingcontaining a plurality of ultrasound probes configured to generateultrasound waves, wherein the ultrasound waves are configured to produceimages of inside a body of a patient, and wherein the ultrasound probesare positioned to provide a viewable image field that is at least inpart beneath the body side of the ultrasound probe housing; a needleguide assembly that is connected to a guide channel cut-out or apertureof the ultrasound probe housing at a pivot point within the guidechannel cut-out or aperture and that is rotatable about the pivot point;and one or more adhesion points located on the body side of theultrasound probe housing, each of the one or more adhesion points beingconfigured to adhere the ultrasound probe housing in location on thebody of the patient.
 2. The device of claim 1, wherein at least one ofthe one or more adhesion points comprises a pronounced outer edge. 3.The device of claim 1, wherein at least one of the one or more adhesionpoints comprises one or more holes in the body side of the ultrasoundprobe housing via which suction can be applied to adhere the ultrasoundprobe housing in location on the body of the patient.
 4. The device ofclaim 3, wherein the at least one of the one or more adhesion pointscomprises a depression in the body side of the ultrasound probe housingthat includes the one or more holes.
 5. The device of claim 4, whereinthe depression is shaped like a channel or a cup.
 6. The device of claim4, further comprising a suction cup disposed along a perimeter of thedepression.
 7. The device of claim 3, wherein the ultrasound probehousing further contains internal tubing or internal channels tofacilitate air exchange via the one or more holes to create the suction.8. The device of claim 1, wherein at least one of the one or moreadhesion points comprises one or more holes in the body side of theultrasound probe housing via which a skin adhesive can be deposited ontothe body of the patient.
 9. The device of claim 8, wherein the at leastone of the one or more adhesion points comprises a depression in thebody side of the ultrasound probe housing that includes the one or moreholes.
 10. The device of claim 1, wherein at least one of the one ormore adhesion points comprises an adhesive pad or film.
 11. The deviceof claim 10, wherein the at least one of the one or more adhesion pointsfurther comprises a removable protective cover disposed over theadhesive pad or film.
 12. The device of claim 10, wherein the adhesivepad or film is one or more of sterile or disposable.
 13. The device ofclaim 10, further comprising a removable cover coupleably joined to allor a portion of the body side of the ultrasound probe housing and uponwhich the adhesive pad or film is disposed.
 14. The device of claim 1,wherein the one or more adhesion points are positioned along a perimeterof the body side of the ultrasound probe housing.
 15. The device ofclaim 1, wherein the one or more adhesion points are located on the bodyside of the ultrasound probe housing in positions that do not interferewith the ability of the ultrasound probes to provide the viewable imagefield.
 16. The device of claim 1, wherein the needle guide assembly isone or more of: radially rotatable about the pivot point; orcircumferentially rotatable about the pivot point.
 17. A devicecomprising: an ultrasound probe housing having an ambient side and abody side, the ultrasound probe housing containing a plurality ofultrasound probes configured to generate ultrasound waves, wherein theultrasound waves are configured to produce images of inside a body of apatient, and wherein the ultrasound probes are positioned to provide aviewable image field that is at least in part beneath the body side ofthe ultrasound probe housing; a guide channel cut-out or aperture thatextends through the ultrasound probe housing from the ambient side tothe body side and through the plurality of ultrasound probes, the guidechannel cut-out or aperture being adapted to accommodate passage of aneedle there through for insertion into the body of the patient suchthat the needle is in the viewable image field that is at least in partbeneath the body side of the ultrasound probe housing upon insertioninto the body of the patient; a needle guide assembly into which theneedle is inserted, wherein the needle guide assembly is connected tothe guide channel cut-out or aperture at a pivot point within the guidechannel cut-out or aperture and is rotatable about the pivot point; andone or more adhesion points located on the body side of the ultrasoundprobe housing, each of the one or more adhesion points being configuredto adhere the ultrasound probe housing in location on the body of thepatient.
 18. The device of claim 17, wherein the one or more adhesionpoints comprise at least a first adhesion point and a second adhesionpoint and wherein the first adhesion point and the second adhesion pointare located on the body side of the ultrasound probe on opposite sidesof the guide channel cut-out or aperture.
 19. The device of claim 17,wherein the one or more adhesion points comprise a plurality of adhesionpoints that substantially surround the guide channel cut-out oraperture.
 20. The device of claim 17, wherein at least one of the one ormore adhesion points comprises a pronounced outer edge.
 21. The deviceof claim 17, wherein at least one of the one or more adhesion pointscomprises one or more holes in the body side of the ultrasound probehousing via which suction can be applied to adhere the ultrasound probehousing in location on the body of the patient.
 22. The device of claim21, wherein the at least one of the one or more adhesion pointscomprises a depression in the body side of the ultrasound probe housingthat includes the one or more holes.
 23. The device of claim 22, whereinthe depression is shaped like a channel or a cup.
 24. The device ofclaim 22, further comprising a suction cup disposed along a perimeter ofthe depression.
 25. The device of claim 21, wherein the ultrasound probehousing further contains internal tubing or internal channels tofacilitate air exchange via the one or more holes to create the suction.26. The device of claim 17, wherein at least one of the one or moreadhesion points comprises one or more holes in the body side of theultrasound probe housing via which a skin adhesive can be deposited ontothe body of the patient.
 27. The device of claim 26, wherein the atleast one of the one or more adhesion point comprises a depression inthe body side of the ultrasound probe housing that includes the one ormore holes.
 28. The device of claim 17, wherein at least one of the oneor more adhesion points comprises an adhesive pad or film.
 29. Thedevice of claim 28, wherein the at least one of the one or more adhesionpoints further comprises a removable protective cover disposed over theadhesive pad or film.
 30. The device of claim 28, wherein the adhesivepad or film is one or more of sterile or disposable.
 31. The device ofclaim 28, further comprising a removable cover coupleably joined to allor a portion of the body side of the ultrasound probe housing and uponwhich the adhesive pad or film is disposed.
 32. The device of claim 17,wherein the one or more adhesion points are positioned along a perimeterof the body side of the ultrasound probe housing.
 33. The device ofclaim 17, wherein the one or more adhesion points are located on thebody side of the ultrasound probe housing in positions that do notinterfere with the ability of the ultrasound probes to provide theviewable image field.
 34. The device of claim 17, wherein the needleguide assembly is one or more of: radially rotatable about the pivotpoint; or circumferentially rotatable about the pivot point.
 35. Aremovable cover that is configured to be coupleably joined to a devicethat comprises an ultrasound probe housing having an ambient side and abody side and a needle guide assembly that is connected to a guidechannel cut-out or aperture of the ultrasound probe housing at a pivotpoint within the guide channel cut-out or aperture and that is rotatableabout the pivot point, the ultrasound probe housing containing aplurality of ultrasound probes configured to generate ultrasound waves,wherein the ultrasound waves are configured to produce images of insidea body of a patient, and wherein the ultrasound probes are positioned toprovide a viewable image field that is at least in part beneath the bodyside of the ultrasound probe housing, wherein: the removable cover isconfigured to be coupleably joined to all or a portion of the body sideof the ultrasound probe housing; and the removable cover comprises oneor more adhesive pads or films that are configured to adhere theultrasound probe housing in location on the body of the patient.
 36. Theremovable cover of claim 35, wherein the one or more adhesive pads arelocated on the removable cover in positions that do not interfere withthe ability of the ultrasound probes to provide the viewable image fieldwhen the removable cover is coupleably joined to the device.
 37. Theremovable cover of claim 35, wherein the needle guide assembly is one ormore of: radially rotatable about the pivot point; or circumferentiallyrotatable about the pivot point.